NCT00031044

Brief Summary

Even though powerful anti-HIV drug combinations have been successful in patients with little or no prior anti-HIV therapy, studies have shown that these treatments are less effective in patients who have been treated with nucleoside analogues. This study will test the safety and effectiveness of adding one or two new drugs to a personalized anti-HIV regimen for patients whose previous HIV treatments have failed.

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Geographic Reach
2 countries

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 20, 2002

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 22, 2002

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
Last Updated

November 1, 2021

Status Verified

October 1, 2021

First QC Date

February 20, 2002

Last Update Submit

October 28, 2021

Conditions

HIV Infections

Keywords

HIV-1Drug Therapy, CombinationRNA, ViralSalvage TherapyAnti-HIV AgentsViral LoadPurinesT-20 PeptideABT 378Treatment Experienced

Interventions

EnfuvirtideDRUG
AmdoxovirDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV infected
  • Taken at least two combination anti-HIV treatments containing three or more drugs. In total, the treatments must have lasted at least 24 months and must have included at least two nucleoside reverse transcriptase inhibitors (NRTIs), two protease inhibitors (PIs), and one nonnucleoside reverse transcriptase inhibitor (NNRTI).
  • Failed two previous combination treatments of three or more drugs
  • Viral load of more than 5000 copies/ml on stable (at least 8 weeks) antiretroviral regimen, within 60 days prior to study entry
  • Willing to stay on the current failing anti-HIV treatment until starting study treatment; may have to remain on failing regimen for an additional 60 days after study screening
  • Willing to use acceptable methods of contraception
  • Access to optimized background (OB) regimen drugs
  • Ability to bring OB regimen drugs to screening visit

You may not qualify if:

  • Prior use of DAPD or ENF
  • Drug or alcohol use which, in the opinion of the investigator, would interfere with the study
  • History of any illness that, in the opinion of the investigator, would interfere with study participation
  • Single kidney or history of two or more episodes of kidney stones
  • Pregnant or breastfeeding
  • Experimental anti-HIV drug use or use of any agent that acts on the immune system within 60 days prior to entry
  • Active immunization within 21 days prior to study entry
  • Acute therapy for a serious infection or illness
  • Active AIDS-defining opportunistic infection requiring acute treatment
  • Unexplained fever within 7 days prior to study entry
  • Cancer that requires chemotherapy
  • Prior HIV vaccination, except for subunit vaccines that contained only gp120
  • Certain mutations in HIV-1 reverse transcriptase
  • Measurable loss of vision due to lens opacity
  • Posterior subcapsular cataract
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Univ of Colorado Health Sciences Ctr

Denver, Colorado, 80262, United States

Location

Miami University

Miami, Florida, United States

Location

Harvard (Massachusetts General Hosp)

Boston, Massachusetts, 02114, United States

Location

Brigham and Womens Hosp

Boston, Massachusetts, 02118, United States

Location

Cornell Univ Med Ctr

New York, New York, 10021, United States

Location

Columbia Presbyterian Med Ctr

New York, New York, 10032, United States

Location

Case Western Reserve Univ

Cleveland, Ohio, 44106, United States

Location

MetroHealth Med Ctr

Cleveland, Ohio, 441091998, United States

Location

Univ of Puerto Rico

San Juan, 00936-5067, Puerto Rico

Location

Related Publications (1)

  • Gripshover BM, Ribaudo H, Santana J, Gerber JG, Campbell TB, Hogg E, Jarocki B, Hammer SM, Kuritzkes DR; A5118 Team. Amdoxovir versus placebo with enfuvirtide plus optimized background therapy for HIV-1-infected subjects failing current therapy (AACTG A5118). Antivir Ther. 2006;11(5):619-23.

    PMID: 16964830RESULT

MeSH Terms

Conditions

HIV Infections

Interventions

Enfuvirtideamdoxovir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Intervention Hierarchy (Ancestors)

Peptide FragmentsPeptidesAmino Acids, Peptides, and ProteinsHIV Envelope Protein gp41Viral Fusion ProteinsMembrane Fusion ProteinsMembrane ProteinsProteinsHIV AntigensAntigens, ViralViral Proteinsenv Gene Products, Human Immunodeficiency VirusGene Products, envRetroviridae ProteinsHuman Immunodeficiency Virus ProteinsViral Envelope ProteinsViral Structural ProteinsAntigensBiological Factors

Study Officials

  • Daniel R. Kuritzkes, MD

    Harvard Medical School (HMS and HSDM)

    STUDY CHAIR

  • Scott M. Hammer, MD

    Columbia University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 20, 2002

First Posted

February 22, 2002

Study Completion

November 1, 2004

Last Updated

November 1, 2021

Record last verified: 2021-10

Locations

US(8)PR(1)